Webinar Reimbursement of Innovative Medical Devices in Germany

1. Webinar Reimbursement of Innovative Medical Devices in Germany Agency for Health Economic Assessment and Dissemination

2. MArS and AHEAD are two separate consulting agencies that collaborate in order to offer high quality market access and reimbursement solutions for the European healthcare setting MArS UG – Market Access & Pricing Strategy • Market access & pricing as well as global clinical development strategies from a health care payer's perspective in the various lifecycle stages of a medical device or pharmaceutical product • German market access strategies and implementation for pharmaceuticals and medical devices AHEAD GmbH is a specialized consulting agency that supports clients • in the planning, generation and dissemination of health economic evidence • as well as in obtaining market access and reimbursement for both medical devices and pharmaceuticals in Germany.

3. MArSand AHEAD are two separate consulting agencies that collaborate in order to offer high quality market access and reimbursement solutions for the European healthcare setting Bjoern Schwander • 12 years experience in market access and health economic consultancy • Various experience in the planning & implementation of the reimbursement of medical devices in Germany • Founder & General Manager of AHEAD based in Germany • Nursing Diploma, BSc in Applied Health Sciences, Master program in Health Economics • > 20 publications & conference presentations Dr. Stefan Walzer • 9+ years experience in market access & pricing strategy and its implementation • Lecturer at the State University Baden-Wuerttemberg (Germany) • Founder & General Manager of MArS based in Germany • Master in Economics, PhD in (Health) Economics, Diploma in Clinical Trials • 30 full text publications • > 60 conference presentations

4. 79 Mio Germans have either private or statutory health insurance coverage and in 2012 the healthcare expenditure on medical devices in Germany reached 25 billion euros

5. For the market access of innovative medical devices in Germany it plays a key role whether a medical device is applied in the inpatient or in the outpatient setting Outpatient Inpatient All innovative procedures are permittedwith the reservation of prohibition (‚Verbotsvorbehalt‘ SGB V §137c) All innovative procedures are prohibited until they have been officially approved (‚Erlaubnisvorbehalt‘ SGBV § 135;1) Within the hospital (inpatient) new CE marked medical devices can be applied as long as they are not actively prohibited by the joint federal committee Before a new medical device can be applied in the outpatient setting a positive voting from the joint federal committee is required Long application process in order to gain approval for applying innovations The hospitals are allowed to apply all CE marked innovations

6. There are several possible reimbursement pathways for innovative medical devices depending on whether a medical device is applied in the inpatient or in the outpatient setting CE Mark Outpatient Inpatient Additional evidence required Inclusion in fee schedules Adequate OPS/DRG available New OPS/DRG required ‘On-top payment required’ Individual health insurance coverage Out of pocket payments Application Experimental Coverage EBM / GOÄ Application OPS/DRG application IGeL Application Already reimbursed NUB (ZE) application Selective Contracts 6 4 5 1 2 3 7

7. The inpatient reimbursement in Germany depends on whether adequate coding (OPS) and adequate coverage (DRG) is available - if not specific applications need to be performed CE Mark Inpatient Adequate OPS/DRG available ‘On-top payment required’ New OPS/DRG required OPS/DRG application Already reimbursed NUB (ZE) application 1 2 3

8. For the reimbursement of inpatient services in Germany a DRG based system is used: Specific DRGs are defined by a combination of disease (ICD) and procedure (OPS) coding ICD-GM Coding OPS Coding German version of the International Statistical Classification of Diseases and Related Health Problems (ICD) German version of the International Classification of Procedures in Medicine (OPS = Operationen- und Prozedurenschlüssel) Specific G-DRG German Diagnosis Related Groups that are linked to a specific reimbursement value

9. Scenario 2a - after performing an initial coding/coverage research it is obtained that changes in the OPS system are required in order to achieve an adequate reimbursement Application Form OPS application 2a DIMDI (German Institute of Medical Documentation and Information) provides an application form and is the addressee of the OPS application Deadline for OPS changes in the following year is end of February in the current year • Form is released in December • Submission deadline is end of February • Decision is released end of August • Valid from January of the following year The responsible German Medical Society should be involved http://www.dimdi.de/static/de/klassi/ops/vorschlagsverfahren/index.htm#vorschlagsformular

10. Scenario 2b - after performing an initial coding/coverage research it is obtained that changes in the DRG system are required in order to achieve adequate reimbursement DRG application Application Form 2b InEK (Institute for the Hospital Remuneration System) provides an application form and is the addressee for DRG applications Deadline for DRG changes in the following year is end of February in the current year The responsible German Medical Society should be involved • Form is released end of November • Submission Deadline is end of February • Decision is released end of August • Valid from January of the following year http://www.gdrg.de/cms/G-DRG-Vorschlagsverfahren

11. Scenario 3 - after performing an initial coding/coverage research it is obtained that an ‘on-top payment’ is required in order to achieve adequate reimbursement Application Form NUB application 3 InEKprovides an application form and is the addressee for NUB (Neue Untersuchungs- und Behandlungsmethoden) applications Deadline for NUB applications in the following year is end of October in the current year • Form is released in September • Submission deadline is end of October • Decision is released end of January of the following year and the NUB is then valid Each hospital needs to submit an own NUB application – the InEK decides whether a ‘on-top payment’ can be negotiated http://www.gdrg.de/cms/content/download/3636/30201/version/1/file/NUB.exe

12. Obtaining the inpatient reimbursement strategy is a step-wise approach and in the best case it might be obtained that an adequate DRG reimbursement is already available NO OPS code available? OPS application 2a YES NO DRG application 2b Relevant DRG available? YES NO NUB (ZE) application DRG fee adequate? 3 YES 1 Reimbursement is already available!

13. The inpatient reimbursement process is clearly structured and there is no need to provide any specific clinical or health economic evidence during the application process • For the application of a new medical device in the inpatient sector only a CE mark is required. • The reimbursement fee of a new medical device depends on the available coding, grouping & coverage options. • In a first research step an initial coding/coverage research should be performed in order to identify the best strategy for an innovative medical device. • For each reimbursement pathway there are specific application procedures available – with a clear process & timing structure. • There is no need to provide any specific clinical or health economic evidence during the inpatient reimbursement application process.

14. For the outpatient reimbursement there are different strategies available – the best one would be obtaining inclusion in the official fee schedules for outpatient services CE Mark Outpatient Out of pocket payments Individual health insurance coverage Inclusion in fee schedules IGeL Application Selective Contracts EBM/GOÄ Application 6 5 4

15. Scenario 4 – the fee schedule of the statutory health insurance (EBM) and the private health insurance (GOÄ) are valuable reimbursement options for outpatient services Fee Schedules GOÄ inclusion EBM inclusion 4 The joint federal committee decides on ambulatory procedures covered by the statutory health insurance The German Medical Association (Bundesärztekammer) is responsible for applications related to the private health insurance fee schedule (GOÄ) An application needs to present the clinical and economic consequences and should be submitted via the association of statutory health insurance physicians (KBV) An application needs to outline the clinical and economic consequences of the procedure The application should be submitted by a medical KOL A value dossier (rapid HTA) for Germany needs to be submitted to the KBV

16. Scenario 5 ‘IGeL Inclusion’ and scenario 6 ‘Selective Contracts’ represent alternative reimbursement scenarios for outpatient procedures in Germany 5 6 IGeL Inclusion Selective Contracts IGeL – stands for individual health services (IndividuelleGesundheitsleistungen) that have to be paid out of pocket by the patients From 1st January 2012 on the statutory health insurances are allowed to reimburse innovative outpatient procedures (SGB V § 11(6)) The usual way of including a new service to the IGeL list is applying for inclusion to the GOÄ schedule Precondition is that a procedure has not been excluded from reimbursement by the joint federal committee (see EBM inclusion) Once a service is listed in the GOÄ schedule it can be offered by each German physician as IGeL service A strong clinical and economic argumentation is required in order to convince individual health insurance funds

17. EBM Inclusion: Before a method for examination or treatment can be discussed in the Federal Joint Committee (G-BA), an application must be made by one of the G-BA members • Such an application may be made by the neutral members of the G-BA, the Federal Association of Statutory Health Insurance Funds, the National Association of Statutory Health Insurance Physicians (KBV), the National Association of Statutory Health Insurance Dentists (KZBV), the German Hospital Federation (DKG) or the patient representatives. • Each application for discussion must contain a detailed justification, including information on the benefits, medical necessity and cost-effectiveness of the method (i.e. diagnostic or therapeutic medical technology) to be discussed, together with a comparison to methods already available.

18. An application for inclusion of a medical device in the EBM fee schedule requires a rapid HTA report that outlines the clinical and economic consequences of the new procedure Submission of a Rapid HTA Report to the KBV Is the available evidence regarded as adequate? NO YES NEGATIVE G-BA application POSITIVE Consider Selective Contracting EBM Inclusion Consider IGeL Inclusion

19. The outpatient reimbursement process is quite diverse and requires the presentation of specific clinical and health economic evidence during the application process • For the application of a new medical device in the outpatient sector a positive reimbursement decision is mandatory. • The first strategy should be to apply for inclusion in the EBM (statuary health insurance) and GOÄ (private health insurance) fee schedules. • The ‘IGeL inclusion’ (out-off pocket payment) and the ‘Selective Contracting’ (coverage by single/local health insurances) should be seen as fallback strategies. • It is mandatory to provide specific clinical and health economic evidence during the application process.

20. In case that a new medical device has a strong innovative potential and there is an need for obtaining additional evidence there is the possibility to apply for an ‘experimental coverage’ CE Mark Outpatient Inpatient Additional evidence required Application for Experimental Coverage 7

21. Scenario 7 – a very new strategy to obtain (in- or outpatient) reimbursement for innovative medical devices in Germany is the application for an ‘Experimental Coverage’ EpCo application Application Form 7 The joint federal committee (G-BA) decides on whether a medical device is suitable for the ‘EpCoprogramm’ An ‘EpCo’ application needs to point out a strong innovative potential and a high unmet need; the manufacturer needs to carry a specific part of the clinical research costs http://www.g-ba.de/downloads/39-261-1608/2012-11-22_VerfO_137e_Anlagen_I-III.pdf The detailed process, proposed by the G-BA’ is currently reviewed and commented by the German Ministry of Health Medical device manufacturers are allowed to apply for such a experimental coverage by using the specific forms provided by the G-BA

22. Especially for medical devices applied in the outpatient sector the ‘experimental coverage’ program provides an additional valuable reimbursement access strategy Submission of a Rapid HTA Report to the KBV Is the available evidence regarded as adequate? YES NO NEGATIVE G-BA application Strong innovative potential & unmet medical need? NO YES POSITIVE Experimental Coverage Application Consider IGeL Inclusion [Selective Contracting] EBM Inclusion

23. The ‘Experimental Coverage’ program is a new strategy intended to be used for new medical devices with a strong innovative potential combined with a high unmet need • The ‘Experimental Coverage’ program allows medical device manufactures (the first time) to apply for reimbursement directly at the G-BA (usually applications were only possible by G-BA members). • From the manufacturer perspective this strategy is only valuable for medical devices applied in the outpatient sector – as there are currently no strict evidence requirements for the ‘inpatient sector’. • It needs to be taken into account that the manufacturer has to cover a part of the research costs. • A new medical device needs to show a strong innovative potential in a patient population with a high unmet medical need in order to be eligible for reimbursement under the ‘Experimental Coverage’ program.

24. There are several opportunities to obtain reimbursement for an innovative medical device in Germany but there are great difference in the time and evidence requirements CE Mark Outpatient Inpatient Additional evidence required Inclusion in fee schedules Adequate OPS/DRG available New OPS/DRG required ‘On-top payment required’ Individual health insurance coverage Out of pocket payments Application Experimental Coverage EBM/ GOÄ Application OPS/DRG application IGeL Application Already reimbursed NUB (ZE) application Selective Contracts 6 4 5 1 2 3 7

25. In summary the German reimbursement process for inpatient medical devices is faster and requires less clinical evidence compared to outpatient medical devices EBM Outpatient Selective Contracts GOÄ (IGeL) Experimental Coverage Evidence Requirement NUB Inpatient OPS/DRG Time Demand for obtaining Reimbursement

26. MArS and AHEAD are two separate consulting agencies that collaborate in order to offer high quality market access and reimbursement solutions for the European healthcare setting We can support you by performing product specific analyses, developing strategies and implement reimbursement • European Market Access, Pricing and Reimbursement Strategies • Realization of market access, pricing and reimbursement solutions for Germany (and other European countries) • Value Dossiers and HTA Reports • Systematic Literature Reviews • Value based Pricing • Health Economic Evaluations • …

27. Please use our more than 20 years of combined experience in market access, reimbursement, payer strategy and in health economics in order tobring your product ahead Contact: Bjoern Schwander General Manager E-mail: bjoern.schwander@ahead-net.de Homepage: www.ahead-net.de Contact: Stefan Walzer General Manager E-mail: stefan.walzer@marketaccess-pricingstrategy.de Homepage: www.marketaccess-pricingstrategy.de